Intra-assay Precision (Precision within an assay): CV%<8%

Three samples of known concentration were tested twenty times on one plate to assess.

Inter-assay Precision (Precision between assays): CV%<10%

Three samples of known concentration were tested in twenty assays to assess.

To assess the linearity of the assay, samples were spiked with high concentrations of human ES in various matrices and diluted with the Sample Diluent to produce samples with values within the dynamic range of the assay.

Sample

Serum(n=4)

1:200

Average %

87

Range %

80-94

1:400

Average %

93

Range %

88-100

1:800

Average %

92

Range %

86-100

1:1600

Average %

90

Range %

86-98

The recovery of human ES spiked to levels throughout the range of the assay in various matrices was evaluated. Samples were diluted prior to assay as directed in the Sample Preparation section.

Sample Type

Average % Recovery

Range

Serum (n=5)

93

89-98

EDTA plasma (n=4)

94

88-100

These standard curves are provided for demonstration only. A standard curve should be generated for each set of samples assayed.

pg/ml

OD1

OD2

Average

Corrected

1000

1.976

2.034

2.005

1.827

500

1.120

1.167

1.143

0.966

250

0.751

0.728

0.740

0.562

125

0.494

0.519

0.506

0.329

62.5

0.337

0.321

0.329

0.151

31.2

0.242

0.253

0.247

0.070

15.6

0.221

0.214

0.218

0.040

0

0.180

0.175

0.178